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Clinical Trials/NCT03924908
NCT03924908WithdrawnNot Applicable

Impact of Virtual Reality Hypnosis on Pain and Anxiety During Dressings Change in Burn Patients Treated as Outpatients

University of Liege0 sitesStarted: January 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Primary Endpoint
Change in fatigue

Study Overview

Brief Summary

Different non-pharmacological techniques, including hypnosis and virtual reality are currently used as complementary tools in the treatment of pain related to burn injury. A new technique called 'virtual reality hypnosis' (VRH) (Patterson et al., 2004), which encompasses a combination of both tools, is regularly used although its actual function remains unknown to this date. With the goal to improve our understanding of VRH combination effects, it is necessary to elaborate randomized and controlled research studies in order to understand their actual function in individual's perception. 100 patients who are treated as outpatients for burn care will be randomly assigned to virtual reality or VRH. Patients will receive one session of one of these techniques during burn dressing change.Physiological parameters will be recorded during dressing change. Participants will fill in a questionnaire evaluating their tendency to be absorbed and dissociated, and another evaluating their level of perceived immersion. Their level of anxiety, pain, fatigue and relaxation will be evaluated before and after the session. A short interview will also be conducted to give participants the opportunity to openly describe their experience.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Burn patient treated as outpatient
  • Burn surface area > or = 5% of the total body surface area
  • mainly 2nd degree burn

Exclusion Criteria

  • Psychiatric antecedents
  • Claustrophobia
  • Heavy hearing
  • Visual impairment
  • Face burn
  • Conjunctivitis
  • Consent not obtained

Outcomes

Primary Outcomes

Change in fatigue

Time Frame: 5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")

Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No fatigue = 0, maximum fatigue = 10.

Change in anxiety: Visual Analogical Scale (VAS)

Time Frame: 5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")

Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No anxiety = 0, maximum anxiety = 10.

Change in pain perception: Visual Analogical Scale (VAS)

Time Frame: 5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")

Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No pain = 0, maximum pain = 10.

Change in relaxation level

Time Frame: 5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")

Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No relaxation = 0, maximum relaxation = 10.

Secondary Outcomes

  • Level of absorption at the moment(5 minutes after dressing change ("time 1"))
  • Time perception(5 minutes after dressing change ("time 1"))
  • Change in heart rate(5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1"))
  • Level of dissociation at the moment(5 minutes after dressing change ("time 1"))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Anne-Françoise Rousseau

Head of Clinic, principal investigator

University of Liege

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